Submitted by kBLASTER Team on
MELBOURNE, Australia--(BUSINESS WIRE)--Medical device company dorsaVi Ltd (ASX:DVL) has received 510(k) clearance by the US Food and Drug Administration expanding the use of ViMove in the United States.
The expanded functionality and labelling is highly significant because for the first time in the USA it permits the use of ViMove to display lower back and pelvic range of motion from healthy patients (normative data). Clinicians and their patients will now be able to compare how their movements are tracking against a “normal” population based on their age group, and help guide therapy decisions and rehabilitation accordingly.
Importantly, this new expanded labelling also permits dorsaVi to record, assess and report on additional static postures including lumbar lordosis (natural standing posture) and on various sitting postures. The inclusion of the pelvic movement data allows clinicians to independently isolate lumbar spine and pelvic movements.The expanded functionality and labelling is highly significant because for the first time in the USA it permits the use of ViMove to display lower back and pelvic range of motion from healthy patients (normative data). Clinicians and their patients will now be able to compare how their movements are tracking against a “normal” population based on their age group, and help guide therapy decisions and rehabilitation accordingly.
As part of the submission to achieve the new labelling, the ViMove data was validated against sophisticated optical tracking sensors (Vicon) used in biomechanical laboratories, and with a marker set clinically validated against Magnetic Resonance Imaging (MRI) for a range of lumbopelvic movements. All ViMove data for standing and sitting postures was accurate to within 5 degrees.
“This is an important breakthrough for clinicians and patients,” said Andrew Ronchi, CEO of dorsaVi.
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